Performance Comparison Between Comfilcon A and Senofilcon C Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: comfilcon A; Device: senofilcon C

Study type: Interventional

Funder types: Industry

Identifiers

NCT02920957

EX-MKTG-70

Details and patient eligibility

About

The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

Full description

This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.

Enrollment: 88 patients

Sex: All

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

• Is between 18 and 34 years of age (inclusive)
• Has had a self-reported eye exam in the last two years
• Is a spherical soft contact lens wearer
• Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
• Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter.
• Has a contact lens prescription that fits within the available parameters of the study lenses.
• Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so).
• Is willing to comply with the visit schedule

Exclusion criteria

A person will be excluded from the study if he/she:

• Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; > 10 hours/day)

• Presents with clinically significant anterior segment abnormalities

• Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.

• Presents with slit lamp findings that would contraindicate contact lens wear such as:

  • Pathological dry eye or associated findings
  • Significant pterygium, pinguecula, or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from of the limbus
  • Giant papillary conjunctivitis (GCP) worse than grade 1
  • Anterior uveitis or iritis (or history in past year)
  • Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
  • History of corneal ulcers or fungal infections
  • Poor personal hygiene

• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

• Has aphakia, keratoconus or a highly irregular cornea.

• Has presbyopia or has dependence on spectacles for near work over the contact lenses.

• Has undergone corneal refractive surgery.

• Is participating in any other type of eye related clinical or research study.

• Is habitually using rewetting/ lubricating eye drops more than once per day

• Is currently wearing daily disposable lenses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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88 participants in 2 patient groups

comfilcon A

Active Comparator group

Description:

Participants are randomized to wear the comfilcon A lens for one month during the cross over study.

Treatment:

Device: comfilcon A

senofilcon C

Active Comparator group

Description:

Participants are randomized to wear the senofilcon C lens for one month during the cross over study.

Treatment:

Device: senofilcon C